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Behavior, ChildEvolASE-PEANCT05525962

Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.

An observational study of Behavior, Child and Child Development, run by University Hospital, Rouen at 5 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Assess the prevalence of medico-psychological characteristics at the time of placement (M0), their appearance / disappearance and during the two years following placement (M12 and M24) by age group in children / adolescents in Child Protective Services and placed full-time in the structures of Seine-Maritime and Eure… Read more about this study

Who is it for?
Ages Up to 16 yearsHealthy volunteers can take part
What is being tested?
questionnaries, scales, cognitive tests
How many people
300 participants
Where
5 sitesFrance
Study dates
29 Sep 2022to 29 Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Minor (0 to 16 years old) arriving for the first time in child protective system and present full time

Who may be able to join

  • Minor adressed to child protective services
  • Minor placed full time

Who cannot join

  • Non affiliation to social security system
  • Non accompanied minor
  • Minor and/or parfents not understanding french
  • Minor informed and refused participation
  • Parents or tutor having refused participation of their child

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cécile Pourcher contact

02 32 88 82 65 ext. 60892

cecile.pourcher@chu-rouen.fr

Priscille GERARDIN contact

5 sites in 1 country

France5 sites, 5 recruiting

  • IDEFHI

    Canteleu

    Wilfried HEROUIN

    Recruiting

  • Foyer Départementale de l'Enfance

    Évreux

    Sylvie CHASTAN

    Recruiting

  • Centre infantile Raymond Lerch

    Le Havre

    Victorine CORDIER

    Recruiting

  • Centre hospitalier du Belvédère

    Mont-Saint-Aignan

    Catherine LAMOTTE

    Recruiting

  • Fondation les Nids

    Mont-Saint-Aignan

    Alice CHARY

    Recruiting

Other trials in France

About this study

Official title: Facteurs de vulnérabilité/résilience influençant Les Trajectoires développementales et Les modalités Adaptatives d'Enfants et d'Adolescents confiés à l'Aide Sociale à l'Enfance. Cohorte Primo-arrivants.

Assess the prevalence of medico-psychological characteristics at the time of placement (M0), their appearance / disappearance and during the two years following placement (M12 and M24) by age group in children / adolescents in Child Protective Services and placed full-time in the structures of Seine-Maritime and Eure as well as in nursery in Le Havre or Rouen

Being tested
questionnaries, scales, cognitive tests
Keywords
child, preschool, adolescent, psychiatry, psychology, Child Protective Services, social sciences, child protection, social services, psychiatric disorders, attachement, developmental trajectories
Medical subject headings
Child Behavior, Developmental Disabilities, Adolescent Behavior, Neurodevelopmental Disorders, Child Behavior Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • questionnaries, scales, cognitive testsBehavioural

    A first interview is planned with a psycholgist in the weeks following the minor arrival in the structure (M0)

    • M0: cognitive test, psychiatric classification and psychologic assessments
    • M12 and M24: psychiatric classification and psychologic assessments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence and nature of psychiatric disorders according to DSM 5

    assessed by MINI S-KID (International Neuropsychiatric Interview for Children and Adolescents) for 6-18 year olds and DC 0-5 (Diagnostic Classification from 0 to 5 ) for 0 to 5 year olds.

    Measured: At inclusion

  2. Presence and nature of psychiatric disorders according to DSM 5

    assessed by MINI S-KID (International Neuropsychiatric Interview for Children and Adolescents) for 6-18 year olds and DC 0-5 (Diagnostic Classification from 0 to 5 ) for 0 to 5 year olds.

    Measured: 1 year after inclusion

  3. Presence and nature of psychiatric disorders according to DSM 5

    assessed by MINI S-KID (International Neuropsychiatric Interview for Children and Adolescents) for 6-18 year olds and DC 0-5 (Diagnostic Classification from 0 to 5 ) for 0 to 5 year olds.

    Measured: After 2 years

Secondary outcomes (54)

  1. Description of cognitive abilities

    0 to 2 years old : BAYLEY V3 or Brunet Lezine (revised) 3 to 6 years old : WPPSI-IV 7 to 16 years old : WISC-V 16 to 18 years old : WAIS-V

    Measured: At inclusion

  2. Presence of an attachement psychopathological disorder

    Assessed by the strange situation procedure for participants aged from 9 months old to 3 years old Assessed by Attachment story completion test from 4 to 9 years old Assessed by the Inventory of Parents and Peer Attachement from 10 to 18 years old

    Measured: At inclusion

  3. Presence of a Borderline-Personality-Disorder

    Using AbDIB questionnaire from 12 to 18 years old

    Measured: At inclusion

  4. Presence of an emotional and behavioral; self-regulation Disorder

    • 1.5 -18 ans : Child Behavior Checklist (CBCL)

    Measured: At inclusion

  5. Presence of an emotional and behavioral; self-regulation Disorder

    • 6-18 ans : Affective Reactivity Index Child Report and Parent Report (ARI)

    Measured: At inclusion

  6. Presence of an emotional and behavioral; self-regulation Disorder

    • 9-18 ans: Toronto Alexithymia Scale (TAS-20)

    Measured: At inclusion

  7. Presence of an emotional and behavioral; self-regulation Disorder

    • 6-18 ans : Rosenberg self-assessment scale - (RSE)

    Measured: At inclusion

  8. Presence of one or multisensory hallucinations

    6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)

    Measured: At inclusion

  9. Mentalization capacities

    12 to 18 using the Reflective Functioning Questionnaire (RFQ 20)

    Measured: At inclusion

  10. Presence of eating disorder

    2 -18 : SCOFF questionnaire

    Measured: At inclusion

  11. Substance use disorders

    11 to 18 years old using the Detection of alcohol and drugs problems in adolescent (DepAdo)

    Measured: At inclusion

  12. Analyses of adverse life events

    • UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)

    Measured: At inclusion

  13. Analyses of adverse life events

    • 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)

    Measured: At inclusion

  14. Description of care pathway

    using a socio-demographic report (scolarship, medical care and environnement)

    Measured: At inclusion

  15. Coping strategies

    • 12 to 18 years old using the Adolescent Coping Scale (ACS)

    Measured: At inclusion

  16. Coping strategies

    • 7 to 13 years old : Self-Report Coping Scale (SRCS)

    Measured: At inclusion

  17. Coping strategies

    • 12 to 18 years old using the Adolescent Coping Scale (ACS)

    Measured: After 1 year

  18. Coping strategies

    • 7 to 13 years old : Self-Report Coping Scale (SRCS)

    Measured: After 1 year

  19. Coping strategies

    • 12 to 18 years old using the Adolescent Coping Scale (ACS)

    Measured: After 2 years

  20. Coping strategies

    • 7 to 13 years old : Self-Report Coping Scale (SRCS)

    Measured: After 2 years

  21. Presence of depressive symptoms

    12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)

    Measured: At inclusion

  22. Analyses of global functionning

    Using the global assessment functionning

    Measured: At inclusion

  23. Analyses of global functionning

    Using Ages \& Stages Questionnaires Version 3 (ASQ3)

    Measured: At inclusion

  24. Presence of attachement psychopathological disorder

    Assessed by the strange situation procedure for participants aged from 9 months old to 3 years old Assessed by Attachment story completion test from 4 to 9 years old Assessed by the Inventory of Parents and Peer Attachement from 10 to 18 years old

    Measured: 1 year after inclusion

  25. Presence of a Borderline-Personality-Disorder

    Using AbDIB questionnaire from 12 to 18 years old

    Measured: After 1 year

  26. Presence of Emotional and behavioral, self-regulation Disorder

    • 1.5 -18 ans : Child Behavior Checklist (CBCL)

    Measured: 1 year after inclusion

  27. Presence of Emotional and behavioral, self-regulation Disorder

    • 6-18 ans : Affective Reactivity Index Child Report and Parent Report (ARI)

    Measured: 1 year after inclusion

  28. Presence of Emotional and behavioral, self-regulation Disorder

    • 9-18 ans: Toronto Alexithymia Scale (TAS-20)

    Measured: 1 year after inclusion

  29. Presence of Emotional and behavioral, self-regulation Disorder

    • 6-18 ans : Rosenberg self-assessment scale - (RSE)

    Measured: 1 year after inclusion

  30. Presence of one or multisensory hallucinations

    6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)

    Measured: 1 year after inclusion

  31. Mentalization capacities

    12 to 18 years old using the Reflective Functioning Questionnaire (RFQ 20)

    Measured: 1 year after inclusion

  32. Presence of eating disorder

    2 -18 : SCOFF questionnaire

    Measured: 1 year after inclusion

  33. Substance use disorders

    11 to 18 years old using the Detection of alcohol and drugs problems in adolescent (DepAdo)

    Measured: 1 year after inclusion

  34. Analyses of adverse life events

    • UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)

    Measured: 1 year after inclusion

  35. Analyses of adverse life events

    • 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)

    Measured: 1 year after inclusion

  36. Description of care pathway

    using a socio-demographic report (scolarship, medical care and environnement)

    Measured: 1 year after inclusion

  37. Presence of depressive symptoms

    12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)

    Measured: 1 year after inclusion

  38. Analyses of global functionning

    Using the global assessment functionning and the Ages \& Stages Questionnaires Version 3 (ASQ3)

    Measured: 1 year after inclusion

  39. Presence of a attachement psychopathological disorder

    Assessed by the strange situation procedure for participants aged from 9 months old to 3 years old Assessed by Attachment story completion test from 4 to 9 years old Assessed by the Inventory of Parents and Peer Attachement from 10 to 18 years old

    Measured: 2 years after inclusion

  40. Presence of a Borderline-Personality-Disorder

    Using AbDIB questionnaire from 12 to 18 years old

    Measured: 2 years after inclusion

  41. Presence of a Emotional and behavioral self-regulation Disorder

    • 1.5 -18 ans : Child Behavior Checklist (CBCL)

    Measured: 2 years after inclusion

  42. Presence of a Emotional and behavioral self-regulation Disorder

    • 6-18 ans : Affective Reactivity Index Child Report and Parent Report (ARI)

    Measured: 2 years after inclusion

  43. Presence of a Emotional and behavioral self-regulation Disorder

    • 9-18 ans: Toronto Alexithymia Scale (TAS-20)

    Measured: 2 years after inclusion

  44. Presence of a Emotional and behavioral self-regulation Disorder

    • 6-18 ans : Rosenberg self-assessment scale - (RSE)

    Measured: 2 years after inclusion

  45. Presence of one or multisensory hallucinations

    • 6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)

    Measured: 2 years after inclusion

  46. Mentalization capacities

    12 to 18 years old using the Reflective Functioning Questionnaire (RFQ 20)

    Measured: 2 years after inclusion

  47. Presence of eating disorder

    2 -18 : SCOFF questionnaire

    Measured: 2 years after inclusion

  48. Substance use disorders

    11 to 18 years old using the Detection of alcohol and drugs problems in adolescent (DepAdo)

    Measured: 2 years after inclusion

  49. Analyses of adverse life events

    • UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)

    Measured: 2 years after inclusion

  50. Analyses of adverse life events

    • 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)

    Measured: 2 years after inclusion

  51. Analyses of global functionning

    Using the global assessment functionning

    Measured: 2 years after inclusion

  52. Analyses of global functionning

    Using the Ages \& Stages Questionnaires Version 3 (ASQ3)

    Measured: 2 years after inclusion

  53. Description of care pathway

    using a socio-demographic report (scolarship, medical care and environnement)

    Measured: 2 years after inclusion

  54. Presence of depressive symptoms

    12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)

    Measured: 2 years after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2022
  2. Study start29 Sep 2022
  3. Primary completion29 Sep 2027 (estimated)
  4. Study completion29 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05525962
Sponsor's protocol ID
2021/0219/HP
Acronym
EvolASE-PEA
Status last verified
Apr 2024
First submitted
23 Jun 2022
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Behavior, Child and Child Development, run by University Hospital, Rouen at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cécile Pourcher (02 32 88 82 65 ext. 60892, cecile.pourcher@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence and nature of psychiatric disorders according to DSM 5 (time frame: At inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05525962.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.

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